HAN-I-FOAM - alcohol liquid 
Momar Incorporated

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Han-I-Foam 6585 Drug Facts and Label

Drug Facts Box OTC-Active Ingredient Section

Ethyl Alcohol 62%

Drug Facts Box OTC-Purpose Section

Antiseptic

Drug Facts Box OTC-Indications & Usage Section

for hand-washing to decrease bacteria on the skin, only when water is not available

Drug Facts Box OTC-Warnings Section

FLAMMABLE, keep away from fire and flames

For external use only

Drug Facts Box OTC-When Using Section

do not get into eyes

if contact occurs, rinse eyes thoroughly with water

Drug Facts Box OTC-Stop Use Section

irritation and redness develop

Drug Facts Box OTC-Keep Out of Reach of Children Section

if swallowed, get medical help or contact a Poison Control Center right away

Drug Facts Box OTC-Dosage & Administration Section

press pump twice to deliver two squirts (about a quarter size) of foaming product onto the palm of your hand

rub hands together and allow to dry without wiping

Drug Facts Box OTC-Inactive Ingredient Section

water, PEG-10 acrylate, perfluorohexylethyl acrylate copolymer, propylene glycol, fragrance

Han-I-Foam 6585

product label

product label

Han-I-Foam 6585

HAN-I-FOAM  
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63533-855
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PEG-10 ACRYLATE/PERFLUOROHEXYLETHYL ACRYLATE COPOLYMER (UNII: D76Z87928N)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63533-855-17532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/10/2020
2NDC:63533-855-1850 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/10/2020
3NDC:63533-855-143785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/10/2020
4NDC:63533-855-101000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product08/10/2020
5NDC:63533-855-111000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/10/2020
6NDC:63533-855-121000 mL in 1 BAG; Type 0: Not a Combination Product08/10/2020
7NDC:63533-855-081 in 1 BOX08/10/2020
71000 mL in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/10/2020
Labeler - Momar Incorporated (003266616)
Registrant - ABC Compounding Co., Inc. (003284353)
Establishment
NameAddressID/FEIBusiness Operations
ABC Compounding Co., Inc.003284353manufacture(63533-855)

Revised: 8/2020
Document Id: 032b0f35-b441-434a-817c-6185a8b82158
Set id: 5045c8ff-7591-47b0-b219-aba27a6fe039
Version: 4
Effective Time: 20200810
 
Momar Incorporated